Midazolam maleate
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy.
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Brand Name | Status | Last Update |
|---|---|---|
| midazolam | ANDA | 2024-12-26 |
| midazolam hcl | unapproved drug other | 2016-04-06 |
| midazolam hydrochloride | ANDA | 2024-12-18 |
| midazolam in sodium chloride | ANDA | 2024-08-16 |
| mkh dose pack | unapproved drug other | 2019-03-05 |
| mko melt dose pack | unapproved drug other | 2019-03-04 |
| n/a | New Drug Application | 2024-05-09 |
| nayzilam | New Drug Application | 2023-01-19 |
| seizalam | New Drug Application | 2023-01-26 |
| versed guards up daily mineral sunscreen broad spectrum spf 35 | OTC monograph final | 2022-08-30 |
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Agency Specific
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Expiration | Code | ||
|---|---|---|---|
MIDAZOLAM, NAYZILAM, UCB INC | |||
| 2026-05-17 | ODE-243 | ||
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT | |||
| 2025-09-14 | ODE-207 | ||
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1534 clinical trials
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Indications Phases 4
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Muscular atrophy | D009133 | HP_0003202 | — | 1 | — | — | — | — | 1 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | — | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | 1 | — | — | — | — | 1 |
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Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Midazolam maleate |
| INN | midazolam |
| Description | Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes. |
| Classification | Small molecule |
| Drug class | Benzodiazepine |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 59467-70-8 |
| RxCUI | 6960 |
| ChEMBL ID | CHEMBL2106922 |
| ChEBI ID | — |
| PubChem CID | 4192 |
| DrugBank | DB00683 |
| UNII ID | R60L0SM5BC (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Midazolam, Midazolam hydrochloride, Midazolam in sodium chloride, N/a, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
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14,626 adverse events reported
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